Clareon SY60WF (UDI 00380652251440)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
Quick summary
This Alcon Clareon SY60WF is an implantable intraocular lens, the type used to replace a clouded natural lens during cataract surgery. Most of the 28 reports describe handling problems in the operating room: the lens scratching, cracking or splitting, breaking into pieces during implantation, bent haptics, or failing to unfold properly in the eye, sometimes requiring removal and replacement with another lens. Four reports involve patient injury, including blurred vision after surgery. No deaths were reported and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652251440), received between Jul 21, 2022 and Jul 31, 2026 — classified as 3 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Scratched Material5
- Break3
- Defective Device3
- Material Split, Cut or Torn3
- Material Twisted/Bent3
- Product Quality Problem3
- Crack2
- Device Dislodged or Dislocated2
Patient problems
- Insufficient Information19
- No Clinical Signs, Symptoms or Conditions6
- Blurred Vision2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50096619 ↗MalfunctionJun 16, 2026Material Split, Cut or Torn
A NON¿HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS HAD A CRACK AT THE HAPTIC¿OPTIC JUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25520528 ↗MalfunctionMay 22, 2026Material Split, Cut or Torn
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS BROKEN AND HENCE THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 25257274 ↗InjuryMay 18, 2026Device Dislodged or Dislocated
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION AND THE LENS WAS TILTING. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL DIFFERENT DIOPTER COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL BREAKDOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO FURTHER PATIENT IMPACT.
Patient problems: Blurred Vision
MAUDE report 25199465 ↗MalfunctionMay 4, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BENT WHEN LOADED. THERE WAS NO PATIENT CONTACT.ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25071118 ↗MalfunctionApr 1, 2026Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WITH DESCRIPTION OF DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE LENS DID NOT UNFOLD IN THE EYE. SURGERY WAS COMPLETED ON THE ON THE SAME DAY WITH ANOTHER UNSPECIFIED LENS WITHOUT ANY HARM TO THE PATIENT. IN SURGEON OPINION THE PATIENT CONDITION WAS GOOD AND THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754897 ↗MalfunctionMar 9, 2026Product Quality Problem
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24544029 ↗InjuryMar 7, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR OCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND EXCHANGED WITH MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Blurred Vision
MAUDE report 24539874 ↗MalfunctionFeb 10, 2026Product Quality Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE FOUR MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 4.
Patient problems: Insufficient Information
MAUDE report 24304192 ↗MalfunctionJan 7, 2026Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS EXPLANTED AND MARKED AS DEFECTIVE REPORTED VIA A REPLY CARD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23989197 ↗MalfunctionJan 3, 2026Material Twisted/Bent
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WOULD NOT FOLD CORRECTLY.
Patient problems: Insufficient Information
MAUDE report 23953775 ↗MalfunctionDec 30, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
A SURGEON REPORTED DURING A PHACOEMULSIFICATION (PHACO) AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS INCORRECTLY POSITIONED IN THE NARROW PART OF THE CARTRIDGE, WHICH LED TO PINCHING AND DETACHMENT OF THE HAPTIC ELEMENT FROM THE OPTICAL PART OF THE IOL AS IT EXITED THE CARTRIDGE. THIS WAS DISCOVERED IN THE CAPSULAR BAG. THE LENS WITH THE DETACHED HAPTIC WAS EXPLANTED, AND AN IDENTICAL IOL WAS IMPLANTED. THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. THE TEMPERATURE CONDITIONS FOR STORING AND USING THE OVD AND THE IOL WERE MAINTAINED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING IN THE SURGEON'S OPINION THE SURGEON BELIEVED THE ISSUE WAS WITH THE LENS. SURGEON CONSIDERED THAT SUSPECT LENS WAS LESS DURABLE THAN OTHER MODEL OF SAME COMPANY LENS AND THAT PROBLEMS WITH IT OCCUR MORE FREQUENTLY. LENS WAS REPLACED IMMEDIATELY DURING THE SURGERY WITH A SIMILAR LENS AVAILABLE AT THE CLINIC.
Patient problems: Insufficient Information
MAUDE report 23931415 ↗MalfunctionOct 22, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING INTRAOCULAR LENS (IOL) DURING IMPLANT PROCEDURE, CRIMPED HAPTIC WAS DISCOVERED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23356454 ↗MalfunctionSep 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED BUT HAD TO BE IMMEDIATELY EXPLANTED DUE TO THE LENS WAS CRACKED.ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22963011 ↗MalfunctionMar 12, 2025Break; Break
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS WAS INSERTED AND REPLACED WITH SECOND PRIMARY REPLACEMENT INTRAOCULAR LENS.
Patient problems: Insufficient Information
MAUDE report 21583039 ↗MalfunctionDec 13, 2024Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS SCRATCHED DURING LOADING. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20923371 ↗MalfunctionDec 5, 2024Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAVING SOME ISSUES LENS BEING SCRATCHED. IT HAPPENED TODAY WITH TWO DIFFERENT TECHS. BUT THE FIRST TIME IT HAPPENED IT WAS IN THE CENTER OF THE LENS, THAT ONE WAS REMOVED AND A NEW ONE PLACED, THE SECOND LENS HAD AN ALMOST IDENTICAL MARK ON IT. SO IT HAD TO BE REPLACED AS WELL. WE SWAPPED OUT CARTRIDGES, THINKING IT COULD BE A FLAW IN A LOT NUMBER, BUT IT STILL HAPPENED. IT HAS HAPPENED WITH DIFFERENT SIZES AND STYLE OF LENSES, AND WE HAVE USED DIFFERENT INSTRUMENT SETS EACH TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 20856435 ↗MalfunctionNov 21, 2024Failure to Advance; Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE LENS GOT STUCK IN THE CARTRIDGE. THE SURGEON ATTEMPTED TO IMPLANT THE LENS, IT CAME OUT PART WAY AND WOULDN'T COME OUT COMPLETELY, SO THE SECOND LENS WAS OPENED AND IMPLANTED. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748524 ↗MalfunctionFeb 6, 2024Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY ,THE PHYSICIAN NOTICED SMALL SPOTS ON ANTERIOR SURFACE OF IOL,PRECIPITATES VS MINOR PINPOINT SCRATCHES, WHICH WAS HARD TO TELL. ALSO PHYSICIAN HOPE THAT THERE WERE NO EFFECTS AND WILL HAVE TO SEE HOW THE PATIENT LOOKS NEXT WEEK. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18650037 ↗MalfunctionNov 27, 2023Scratched Material; Scratched Material
ADDITIONAL INFORMATION RECEIVED AND STATED THAT NO MALFUNCTION WITH THE LENS. WITH AVAILABLE INFORMATION, THE FILE WAS REVIEWED AND REASSESSED AND IT HAS BEEN DETERMINED THAT THERE WAS NO REPORTED DEFECT OR FAULT WITH A COMPANY PRODUCT.
Patient problems: Insufficient Information
MAUDE report 18208351 ↗MalfunctionSep 25, 2023Defective Device; Defective Device
AN ACCOUNT MANAGER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS DEFECTIVE AND LENS WAS EXPLANTED AT THE INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 17807237 ↗InjuryAug 18, 2023Crack; Device Dislodged or Dislocated; Crack; Device Dislodged or Dislocated
A NURSE REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS SLIGHTLY OFF CENTER OBSERVED POST THREE WEEK OF INITIAL IMPLANTATION. THE SURGEON RECOMMENDED THAT PATIENT HAVE SURGERY TO ATTEMPT TO RECENTER THE LENS WITH A POSSIBLE EXCHANGE. AT THE BEGINNING OF THE CASE IT WAS NOTED THAT THERE WAS A CRACK AT THE OPTIC HAPTIC JUNCTION. WHILE ATTEMPTING TO BRING THE LENS INTO THE ANTERIOR CHAMBER, THAT HAPTIC FELL OFF. THAT HAPTIC WAS REMOVED FROM THE EYE. THE SURGEON CONTINUED ATTEMPTING TO BRING THE REMAINING PORTION OF THE LENS INTO THE ANTERIOR CHAMBER WHEN THE SECOND HAPTIC JUST FELL OFF. THAT HAPTIC WAS THEN REMOVED AS WELL AND THE LENS BODY WAS REMOVED. A NEW LENS WAS REPLACED.
Patient problems: Insufficient Information
MAUDE report 17571316 ↗MalfunctionApr 25, 2023Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL (TEAM LEADER) REPORTED THAT DURING THE INTRAOCULAR LENS (IOL), IMPLANT PROCEDURE LENS FOUND BE A DAMAGED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 7 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16807738 ↗MalfunctionApr 25, 2023Defective Device; Defective Device
A NON HEALTH CARE PROFESSIONAL (TEAM LEADER) REPORTED THAT DURING THE INTRAOCULAR LENS (IOL), IMPLANT PROCEDURE LENS FOUND BE A DAMAGED. THERE ARE TWELVE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 8 OF 12. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16807525 ↗MalfunctionApr 4, 2023Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED WHEN NEEDED FOR SURGERY. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 16677201 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.